Delivery devices and methods for leadless cardiac devices

ABSTRACT

Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example delivery device may include an intermediate tubular member and an inner tubular member slidably disposed within a lumen of the intermediate tubular member. A distal holding section may extend distally of a distal end of the intermediate tubular member and define a cavity therein for receiving an implantable leadless pacing device. The device may be configured to enable fluid flushing of the delivery device prior to use, to remove any air from within the device as well as providing the option of fluid flow during use of the delivery device.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of and priority to U.S.Provisional Patent Application Ser. No. 62/450,727, filed Jan. 26, 2017,the disclosure of which is incorporated herein by reference.

TECHNICAL FIELD

The present disclosure pertains to medical devices, and methods formanufacturing and/or using medical devices. More particularly, thepresent disclosure pertains to leadless cardiac devices and methods,such as leadless pacing devices and methods, and delivery devices andmethods for such leadless devices.

BACKGROUND

A wide variety of medical devices have been developed for medical use,for example, cardiac use. Some of these devices include catheters,leads, pacemakers, and the like, and delivery devices and/or systemsused for delivering such devices. These devices are manufactured by anyone of a variety of different manufacturing methods and may be usedaccording to any one of a variety of methods. Of the known medicaldevices, delivery systems, and methods, each has certain advantages anddisadvantages. There is an ongoing need to provide alternative medicaldevices and delivery devices as well as alternative methods formanufacturing and using medical devices and delivery devices.

BRIEF SUMMARY

This disclosure provides design, material, manufacturing method, and usealternatives for medical devices, including delivery devices. In anexample of the disclosure, a delivery device for delivering animplantable leadless pacing device includes an outer tubular memberhaving an outer tubular member lumen extending from a proximal end to adistal end thereof and an intermediate tubular member that is coaxiallyand slidingly disposed within the outer tubular member lumen and itselfincludes an intermediate tubular member lumen extending from a proximalend to a distal end thereof. An inner tubular member is coaxially andslidingly disposed within the intermediate tubular member lumen anditself includes an inner tubular member lumen extending from a proximalend to a distal end thereof. A distal holding section extends distallyof a distal end of the intermediate tubular member and defines a cavitytherein for receiving an implantable leadless pacing device. Adeployment funnel is secured relative to the distal end of the innertubular member and is moveable between an advanced position in which thedeployment funnel extends distally within the distal holding section anda retracted position in which the deployment funnel is seated within aproximal portion of the distal holding section. The deployment funnel isconfigured to permit fluid flow from the distal end of the intermediatetubular member lumen into the distal holding section when the deploymentfunnel is in the retracted position.

Alternatively or additionally to any embodiment above, the deploymentfunnel may include one or more apertures extending through thedeployment funnel that are in fluid communication with the intermediatetubular member lumen so that fluid can flow from the distal end of theintermediate tubular member lumen and pass through the one or moreapertures into the distal holding section.

Alternatively or additionally to any embodiment above, the deploymentfunnel may include one or more grooves that are in fluid communicationwith the intermediate tubular member lumen so that fluid can flow fromthe distal end of the intermediate tubular member lumen and pass throughthe one or more grooves into the distal holding section.

Alternatively or additionally to any embodiment above, at least aportion of the deployment funnel may include a porous material thatenables fluid flow through pores thereof.

Alternatively or additionally to any embodiment above, at least aportion of the deployment funnel may include a scaffolding materialincluding voids that enable fluid flow therethrough.

Alternatively or additionally to any embodiment above, the deploymentfunnel may be further configured to provide a fluid coupling between theinner tubular member lumen and the distal holding section when thedeployment funnel is in the retracted position.

Alternatively or additionally to any embodiment above, the deploymentfunnel may include a central aperture that aligns with the inner tubularmember lumen.

Alternatively or additionally to any embodiment above, the inner tubularmember lumen may extend proximally to a fluid port.

Alternatively or additionally to any embodiment above, the intermediatetubular member lumen may extend proximally to a fluid port.

In another example of the disclosure, a delivery device for deliveringan implantable leadless pacing device includes an outer tubular memberdefining an outer tubular member lumen extending from a proximal end toa distal end thereof and an intermediate tubular member that is moveablydisposed within the outer tubular member lumen and itself defines anintermediate tubular member lumen extending from a proximal end to adistal end thereof. A distal holding section extends distally of adistal end of the intermediate tubular member and is configured toaccommodate an implantable leadless pacing device at least partiallywithin the distal holding section. The intermediate tubular member ismoveable between a retracted position in which a proximal portion of thedistal holding section seats within the outer tubular member lumen andan extended position in which the proximal portion of the distal holdingsection extends distally from the outer tubular member lumen. An innertubular member is moveably disposed within the intermediate tubularmember lumen and itself defines an inner tubular member lumen extendingfrom a proximal end to a distal end thereof. A deployment funnel issecured relative to the distal end of the inner tubular member and theinner tubular member is moveable between an extended position in whichthe deployment funnel extends distally within the distal holding sectionand a retracted position in which the deployment funnel is seated withina proximal portion of the distal holding section. The deployment funnelis configured to permit fluid flow from the distal end of theintermediate tubular member lumen into the distal holding section whenin the retracted position.

Alternatively or additionally to any embodiment above, the deploymentfunnel may include one or more apertures extending through thedeployment funnel in order to permit fluid to flow past the deploymentfunnel in the retracted position.

Alternatively or additionally to any embodiment above, the deploymentfunnel may include one or more grooves on a surface of the deploymentfunnel in order to permit fluid to flow past the deployment funnel inthe retracted position.

Alternatively or additionally to any embodiment above, at least aportion of the deployment funnel may include a porous material thatenables fluid flow therethrough.

Alternatively or additionally to any embodiment above, the outer tubularmember lumen may extend proximally to a fluid port such that the outertubular member lumen may be flushed with fluid with the intermediatetubular member in its extended position.

Alternatively or additionally to any embodiment above, the intermediatetubular member lumen may extend proximally to a fluid port such that theintermediate tubular member lumen may be flushed with fluid regardlessof a position of the inner tubular member relative to the intermediatetubular member.

Alternatively or additionally to any embodiment above, the inner tubularmember includes an aperture proximate the distal end thereof providing afluid pathway between the intermediate tubular member lumen and theinner tubular member lumen permitting fluid to pass from theintermediate tubular member lumen into the inner tubular member lumenand distally through the deployment funnel into the distal holdingsection.

Alternatively or additionally to any embodiment above, the intermediatetubular member includes an aperture proximate the distal end thereofproviding a fluid pathway between the outer tubular member lumen and theintermediate tubular member lumen permitting fluid to pass from theouter tubular member lumen into the intermediate tubular member lumenand distally into the distal holding section.

In another example of the disclosure, a delivery system for delivering aleadless cardiac pacemaker (LCP) includes a deflection shaft defining adeflection shaft lumen and an extension shaft extending through thedeflection shaft lumen, the extension shaft defining an extension shaftlumen. An LCP sleeve is secured to a distal end of the extension shaftand extends distally therefrom, the LCP sleeve configured to accommodatean LCP at least partially within the LCP sleeve for delivery. Adeployment shaft extends through the extension shaft lumen and itselfdefines a deployment shaft lumen. A deployment funnel is secured to adistal end of the deployment shaft and is configured to engage the LCPfor holding the LCP in place while the LCP sleeve is withdrawnproximally relative to the LCP. The deployment funnel is configured toaccommodate a tether extending within the deployment shaft lumen andthrough a central aperture of the deployment funnel that aligns with thedeployment shaft lumen, the deployment funnel including one or morefluid structures that enable fluid to flow from the extension shaftlumen and distally beyond the deployment funnel into the LCP sleeve.

Alternatively or additionally to any embodiment above, the deliverysystem may further include a handle assembly configured to control aposition of the deployment shaft relative to the extension shaft and/ora position of the extension shaft relative to the deflection shaft.

Alternatively or additionally to any embodiment above, the handleassembly may include a first fluid port fluidly coupled with thedeflection shaft lumen.

Alternatively or additionally to any embodiment above, the handleassembly may include a second fluid port fluidly coupled with theextension shaft lumen.

Alternatively or additionally to any embodiment above, the handleassembly may include a third fluid port fluidly coupled with thedeployment shaft lumen.

Alternatively or additionally to any embodiment above, the deploymentfunnel comprises one or more grooves on a surface of the deploymentfunnel in order to permit fluid to flow past the deployment funnel intothe LCP sleeve.

Alternatively or additionally to any embodiment above, the one or moregrooves are formed on a radially outward facing surface of thedeployment funnel seated against a hub portion of the LCP sleeve.

Alternatively or additionally to any embodiment above, the one or moregrooves are formed on a radially inward facing surface of the deploymentfunnel seated against a head portion of a docking member of the LCP.

Alternatively or additionally to any embodiment above, the deploymentshaft includes an aperture extending through a sidewall thereofproviding a fluid pathway between the extension shaft lumen and thedeployment shaft lumen permitting fluid to pass from the extension haftlumen into the deployment shaft lumen and distally through thedeployment funnel into the LCP sleeve.

The above summary of some embodiments is not intended to describe eachdisclosed embodiment or every implementation of the present disclosure.The Figures, and Detailed Description, which follow, more particularlyexemplify some of these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of thefollowing detailed description in connection with the accompanyingdrawings, in which:

FIG. 1 is a plan view of an example leadless pacing device implantedwithin a heart;

FIG. 2 is a side view of an example implantable leadless cardiac pacingdevice;

FIG. 3 is a plan view of an example delivery device for an implantableleadless cardiac pacing device;

FIG. 4 is a partial cross-sectional side view of the distal portion ofthe delivery device of FIG. 3;

FIG. 5 is a top view of the handle of the illustrative delivery deviceof FIG. 3;

FIG. 6 is a bottom view of the handle of the illustrative deliverydevice of FIG. 3;

FIG. 7 is an enlarged partial cross-sectional view of a portion of theillustrative delivery device of FIG. 3, showing fluid paths through thedelivery device;

FIG. 8 is an enlarged partial cross-sectional view of a portion of theillustrative delivery device of FIG. 3, showing fluid paths through thedelivery device;

FIG. 9A is an end view of a deployment funnel that can be used as aportion of the delivery device of FIG. 3;

FIG. 9B is a cross-sectional view of the deployment funnel of FIG. 9A,taken along the 9B-9B line;

FIG. 10 is an enlarged partial cross-sectional view of a portion of anillustrative delivery device, showing fluid paths through the deliverydevice;

FIG. 11A is an end view of a deployment funnel that can be used as aportion of the delivery device of FIG. 10;

FIG. 11B is a perspective view of the deployment funnel of FIG. 11A;

FIG. 11C is a perspective view of another deployment funnel that can beused as part of the delivery device of FIG. 10;

FIG. 11D is an end view of the deployment funnel of FIG. 11C;

FIG. 11E is a perspective view of the deployment funnel of FIG. 11Cengaged with an implantable device;

FIG. 12 is an enlarged partial cross-sectional view of an illustrativedelivery device showing fluid paths through the delivery device;

FIG. 13 is a plan view of a deployment funnel that can be used as aportion of the delivery devices of FIGS. 3, 10 and 12; and

FIG. 14 is a plan view of a deployment funnel and inner tubular memberthat can be used as a portion of the delivery devices of FIGS. 3, 10 and12.

While the disclosure is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the invention tothe particular embodiments described. On the contrary, the intention isto cover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the disclosure.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (i.e., having the same function orresult). In many instances, the terms “about” may include numbers thatare rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

It is noted that references in the specification to “an embodiment”,“some embodiments”, “other embodiments”, etc., indicate that theembodiment described may include one or more particular features,structures, and/or characteristics. However, such recitations do notnecessarily mean that all embodiments include the particular features,structures, and/or characteristics. Additionally, when particularfeatures, structures, and/or characteristics are described in connectionwith one embodiment, it should be understood that such features,structures, and/or characteristics may also be used connection withother embodiments whether or not explicitly described unless clearlystated to the contrary.

The following detailed description should be read with reference to thedrawings in which similar structures in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of thedisclosure.

Cardiac pacemakers provide electrical stimulation to heart tissue tocause the heart to contract and thus pump blood through the vascularsystem. Conventional pacemakers typically include an electrical leadthat extends from a pulse generator implanted subcutaneously orsub-muscularly to an electrode positioned adjacent the inside or outsidewall of the cardiac chamber. As an alternative to conventionalpacemakers, self-contained or leadless cardiac pacemakers have beenproposed. Leadless cardiac pacemakers are small capsules typically fixedto an intracardiac implant site in a cardiac chamber. The small capsuletypically includes bipolar pacing/sensing electrodes, a power source(e.g. a battery), and associated electrical circuitry for controllingthe pacing/sensing electrodes, and thus provide electrical stimulationto heart tissue and/or sense a physiological condition. The capsule maybe delivered to the heart using a delivery device which may be advancedthrough a femoral vein, into the inferior vena cava, into the rightatrium, through the tricuspid valve, and into the right ventricle.Accordingly, it may be desirable to provide delivery devices whichfacilitate advancement through the vasculature.

FIG. 1 illustrates an example implantable leadless cardiac pacing device10 (e.g., a leadless pacemaker) implanted in a chamber of a heart H,such as the right ventricle RV. In some cases, the implantable device 10may be referred to as being a leadless cardiac pacemaker (LCP). A sideview of the illustrative implantable device 10 is shown in FIG. 2. Theimplantable device 10 may include a shell or housing 12 having aproximal end 14 and a distal end 16. The implantable device 10 mayinclude a first electrode 20 positioned adjacent to the distal end 16 ofthe housing 12 and a second electrode 22 positioned adjacent to theproximal end 14 of the housing 12. For example, housing 12 may include aconductive material and may be insulated along a portion of its length.A section along the proximal end 14 may be free of insulation so as todefine the second electrode 22. The electrodes 20, 22 may be sensingand/or pacing electrodes to provide electro-therapy and/or sensingcapabilities. The first electrode 20 may be capable of being positionedagainst or may otherwise contact the cardiac tissue of the heart H whilethe second electrode 22 may be spaced away from the first electrode 20,and thus spaced away from the cardiac tissue.

The implantable device 10 may include a pulse generator (e.g.,electrical circuitry) and a power source (e.g., a battery) within thehousing 12 to provide electrical signals to the electrodes 20, 22 andthus control the pacing/sensing electrodes 20, 22. Electricalcommunication between the pulse generator and the electrodes 20, 22 mayprovide electrical stimulation to heart tissue and/or sense aphysiological condition.

The implantable device 10 may include a fixation mechanism 24 proximatethe distal end 16 of the housing 12 configured to attach the implantabledevice 10 to a tissue wall of the heart H, or otherwise anchor theimplantable device 10 to the anatomy of the patient. As shown in FIG. 1,in some instances, the fixation mechanism 24 may include one or more, ora plurality of hooks or tines 26 anchored into the cardiac tissue of theheart H to attach the implantable device 10 to a tissue wall. In otherinstances, the fixation mechanism 24 may include one or more, or aplurality of passive tines, configured to entangle with trabeculaewithin the chamber of the heart H and/or a helical fixation anchorconfigured to be screwed into a tissue wall to anchor the implantabledevice 10 to the heart H.

The implantable device 10 may include a docking member 30 proximate theproximal end 14 of the housing 12 configured to facilitate deliveryand/or retrieval of the implantable device 10. For example, the dockingmember 30 may extend from the proximal end 14 of the housing 12 along alongitudinal axis of the housing 12. The docking member 30 may include ahead portion 32 and a neck portion 34 extending between the housing 12and the head portion 32. The head portion 32 may be an enlarged portionrelative to the neck portion 34. For example, the head portion 32 mayhave a radial dimension from the longitudinal axis of the implantabledevice 10 which is greater than a radial dimension of the neck portion34 from the longitudinal axis of the implantable device 10. The dockingmember 30 may further include a tether retention structure 36 extendingfrom the head portion 32. The tether retention structure 36 may definean opening 38 configured to receive a tether or other anchoringmechanism therethrough. While the retention structure 36 is shown ashaving a generally “U-shaped” configuration, the retention structure 36may take any shape which provides an enclosed perimeter surrounding theopening 38 such that a tether may be securably and releasably passed(e.g. looped) through the opening 38. The retention structure 36 mayextend though the head portion 32, along the neck portion 34, and to orinto the proximal end 14 of the housing 12. The docking member 30 may beconfigured to facilitate delivery of the implantable device 10 to theintracardiac site and/or retrieval of the implantable device 10 from theintracardiac site. Other docking members 30 are contemplated.

One aspect of the current disclosure relates to the delivery deviceand/or system used, for example, to deliver device 10 to a suitablelocation within the anatomy (e.g., the heart). As may be appreciated,the delivery device may need to be navigated through relatively tortuousanatomy to deliver the device 10 to a suitable location. For instance,in some embodiments, the delivery device may be advanced through thevasculature to a target region. In some example cases the device may beadvanced through a femoral vein, into the inferior vena cava, into theright atrium, through the tricuspid valve, and into the right ventricle.The target region for the delivery of the device 10 may be a portion ofthe right ventricle, for example, a portion of the right ventricle nearthe apex of the heart. The target region may also include other regionsof the heart (e.g., right atrium, left atrium, or left ventricle), bloodvessels, or other suitable targets. It may be desirable to provide thedelivery system with certain features that may allow for easier orbetter control for navigation or delivery purposes.

FIG. 3 is a plan view of an illustrative delivery device 100, such as acatheter, that may be used to deliver the implantable device 10. Thedelivery device 100 may include an outer tubular member 102 having aproximal section 104 and a distal section 106. In some cases, the outertubular member 102 may be considered as being a deflection shaft. Anintermediate tubular member 110 may be longitudinally slidably disposedwithin an outer tubular member lumen 150 (or a deflection shaft lumen)of the outer tubular member 102 (see e.g. FIG. 4). The intermediatetubular member 110 may be considered as being an extension shaft. Aninner tubular member 116 may be longitudinally slidably disposed withinan intermediate tubular member lumen 152 (or extension shaft lumen) ofthe intermediate tubular member 110 (see e.g. FIG. 4). A distal holdingsection 108 may be attached to a distal end portion 114 of theintermediate tubular member 110. In some cases, the distal holdingsection 108 may be considered as being an LCP sleeve, particularly ifconfigured to accommodate a leadless cardiac pacemaker (LCP) as theimplantable device 10. The delivery device 100 may also include a handleassembly 120 positioned adjacent to the proximal section 104 of theouter tubular member 102. In some embodiments, the outer tubular member102 may include at least a section thereof that has an outer diameter D2that is less than the outer diameter D1 of at least a portion of theholding section 108 (see e.g. FIG. 4).

The handle assembly 120 may include a first or distal hub portion 126attached to, such as fixedly attached to, the proximal end section 104of the outer tubular member 102, a second or intermediate hub portion128 attached to, such as fixedly attached to, a proximal end section ofthe intermediate tubular member 110, and a third or proximal hub portion130 attached to, such as fixedly attached to, a proximal end section ofthe inner tubular member 116 (see e.g. FIG. 4). In some cases, the innertubular member 116 may be considered as being a deployment shaft. Thefirst hub portion 126, second hub portion 128, and third hub portion 130may be positioned in a generally telescoping arrangement andlongitudinally slidable relative to each other. As will be discussed inmore detail below, each of the first hub portion 126, the second hubportion 128, and the third hub portion 130 may be longitudinallyslidable and rotatable relative to each other such that the outertubular member 102, intermediate tubular member 110, and inner tubularmember 116 may be individually actuated. In some instances, it may bedesirable to move the outer tubular member 102, intermediate tubularmember 110 and inner tubular member 116 simultaneously. The handleassembly 120 may include a multi-stage deployment mechanism or a firstlocking mechanism 134 to releasably couple the second hub portion 128 tothe third hub portion 130 to prevent relative longitudinal movementtherebetween, and thus prevent relative longitudinal movement betweenthe intermediate tubular member 110 and the inner tubular member 116, aswill be discussed in more detail below. The handle assembly 120 may alsoinclude a second locking mechanism 132 to releasably couple the firsthub portion 126 to the second hub portion 128 to prevent relativelongitudinal movement therebetween, and thus prevent relativelongitudinal movement between the outer tubular member 102 and theintermediate tubular member 110, as will be discussed in more detailbelow.

The distal holding section 108 may be configured to receive theimplantable device 10 therein. For example, referring to FIG. 4, whichillustrates a cross-sectional view of a distal portion of deliverydevice 100, the holding section 108 may define a cavity 142 for slidablyreceiving the implantable device 10, and may include a distal opening144 for slidable insertion and/or extraction of the implantable device10 into and/or out of the cavity 142.

The distal holding section 108 may include a body portion 138 and adistal tip portion 140 that may be, for example, configured to beatraumatic to anatomy, such as a bumper tip. For example, as thecatheter is navigated through the anatomy, the distal tip may come intocontact with anatomy. Additionally, when the catheter is used to deliverthe device, the tip 140 of the delivery device 100 will likely come intocontact with tissue adjacent the target site (e.g. cardiac tissue of theheart). A hard distal tip formed of the material of the outer tubularmember 102 and/or intermediate tubular member 110 may injure a vesselwall or cardiac tissue. As such, it may be desirable to provide thedelivery device 100 with a softer distal tip 140 that can be introducedinto the anatomy and come into contact with anatomy adjacent the targetcite without causing unnecessary trauma.

For example, the distal tip 140 may be made of a material that is softerthan the body portion 138 of the distal holding section. In some cases,the distal tip 140 may include a material that has a durometer that isless than the durometer of the material of the body portion 138. In someparticular embodiments, the durometer of the material used in the distaltip 140 may be in the range of about 5 D to about 70 D, or for example,in the range of about 25 D to about 65 D. Additionally, the distal tip140 may include a shape or structure that may make it less traumatic totissue. For example, the distal tip 140 may have a distal surface, suchas a tissue contacting surface, that is that is rounded or includes acurvature configured to be more atraumatic to tissue.

In some embodiments, all or a portion of the distal holding section 108may include an inner surface that may be configured to resist gettingcaught on the fixation mechanism 24, such as the one or more, or aplurality of hooks or tines 26 on the device 10. For example, the distalholding section 108 may include an inner layer or coating of harder ormore lubricious material that resists force applied by the fixationmechanism 24 onto the inner surface of the distal holding section 108.For example, the distal holding section 108 may include a multi-layeredstructure, and an inner layer may be made of a material that is harderthan an outer layer.

The inner tubular member 116 may be disposed (e.g., slidably disposed)within the intermediate tubular member lumen 152 of the intermediatetubular member 110. The inner tubular member 116 may be engaged by auser near or at the third hub portion 130, and extend through theintermediate tubular member lumen 152 of the intermediate tubular member110 and into the distal holding section 108. In some cases, the innertubular member 116 may include a deployment funnel 118 that may, forexample, be capable of engaging the device 10, and the inner tubularmember 116 may be used to “push” the device 10 out from the distalholding section 108 so as to deploy and anchor device 10 within a targetregion (e.g., a region of the heart such as the right ventricle). Theinner tubular member 116 may have an inner tubular member lumen 154extending from the proximal end 117 to and/or through the deploymentfunnel 118. A tether 112 or other retaining feature may be used toreleasably secure the device 10 to the delivery device 100. In someinstances, the tether 112 may be a single or unitary length of materialthat may extend from a proximal end 117 of the inner tubular memberlumen 154, out through the deployment funnel 118, through the opening 38of the device 10 and return to the proximal end 117 of the inner tubularmember 116 through the inner tubular member lumen 154 such that bothends of the tether 112 are positioned adjacent to the third hub portion130. In some instances, the ends of the tether 112 may be secured withina locking feature in the third hub portion 130.

In order to more specifically place or steer the delivery device 100 toa position adjacent to the intended target, the delivery device 100 maybe configured to be deflectable or articulable or steerable. Referringto FIG. 3, for example, the outer tubular member 102 and/or intermediatetubular member 110 may include one or more articulation or deflectionmechanism(s) that may allow for the delivery device 100, or portionsthereof, to be deflected, articulated, steered and/or controlled in adesired manner. For example, the outer tubular member 102 may include atleast a portion thereof that can be selectively bent and/or deflected ina desired or predetermined direction. This may, for example, allow auser to orient the delivery device 100 such that the holding section 108is in a desirable position or orientation for navigation or delivery ofthe device 10 to a target location. The outer tubular member 102 may bedeflected, for example, along a deflection region.

A wide variety of deflection mechanisms may be used. In some exampleembodiments, deflection may be effected by one or more actuationmembers, such as pull wire(s) extending between a distal portion of theouter tubular member 102 and an actuation mechanism 122 near theproximal end of the outer tubular member 102. As such, the one or morepull wires may extend both proximally and distally of the desireddeflection or bending region or point. This allows a user to actuate(e.g., “pull”) one or more of the pull wires to apply a compressionand/or deflection force to at least a portion of the outer tubularmember 102 and thereby deflect or bend the outer tubular member 102 in adesired manner. In addition, in some cases the one or more wires may bestiff enough so that they can also be used to provide a pushing and/ortensioning force on the outer tubular member 102, for example, to “push”or “straighten” the shaft into a desired position or orientation.

In some embodiments, the actuation member takes the form of a continuouswire that is looped through or otherwise coupled to a distal end regionof the outer tubular member 102 so as to define a pair of wire sections.Other embodiments are contemplated, however, including embodiments wherethe actuation member includes one or a plurality of individual wiresthat are attached, for example, to a metal or metal alloy ring adjacentthe distal end region of the outer tubular member 102.

The actuation mechanism 122 may include a desired mechanism that mayallow for applying tension (i.e. pulling force), or compression (i.e.pushing force), or both, on the actuation member(s). In someembodiments, the actuation mechanism 122 may include an externalrotatable member 124 connected to and rotatable about the longitudinalaxis of the handle assembly 120. The rotatable member 124 maythreadingly engage an internal member that is attached to the proximalend of the actuation member(s) or pull wires. When the externalrotatable member 124 is rotated in a first rotational direction, theinternal member translates in a first longitudinal direction, therebyapplying tension to the pull wire(s), which applies compression force tothe shaft, so as to deflect the outer tubular member 102 from an initialposition to a deflected position. When the external rotatable member 124is rotated in a second rotational direction, the internal membertranslates in a second longitudinal direction, thereby reducing and/orreleasing the tension on the pull wire(s), and allowing the outertubular member 102 to relax back toward the initial position.Additionally, in some cases, as mentioned above, where the one or morewires may be stiff enough, rotation of the rotatable member 124 in thesecond rotational direction such that the internal member translates ina second longitudinal direction may apply compression to the wire(s),such that the wire(s) may apply tension to the outer tubular member 102and “push” the outer tubular member 102 back toward an initial position,and possibly into additional positions beyond the initial position.

The one or more articulation and/or deflection mechanism(s) may alsoentail the outer tubular member 102 including structure and/or materialthat may provide for the desired degree and/or location of thedeflection when the compressive or tensile forces are applied. Forexample, the outer tubular member 102 may include one or more sectionsthat include structure and/or material configured to allow the shaft tobend and/or deflect in a certain way when a certain predeterminedcompressive and/or tensile force is applied. For example, the shaft mayinclude one or more sections that are more flexible than other sections,thereby defining a bending or articulating region or location. Some suchregions may include a number of varying or changing flexibilitycharacteristics that may define certain bending shapes whenpredetermined forces are applied. Such characteristics may be achievedthrough the selection of materials or structure for different sectionsof the outer tubular member 102.

In other embodiments, other articulation and/or deflection mechanism(s)are contemplated. For example, all or a portion of the delivery device100, such as the outer tubular member 102, may be made of a shape memorymaterial, such as a shape memory polymer and/or a shape memory metal.Such materials, when stimulated by an actuation mechanism, such as achange in temperature or the application of an electrical current, maychange or move from a first shape to a second shape. As such, thesematerial and mechanism may be used to deflect or bend the outer tubularmember 102 in a desired manner. Other suitable deflection mechanism(s)that are able to deflect the delivery device 100 may also be used. Suchalternative mechanisms may be applied to all other embodiments shownand/or discussed herein, and others, as appropriate.

Furthermore, the outer tubular member 102 may include one or morepredefined or fixed curved portion(s) along the length thereof. In somecases, such curved sections may be configured to fit with particularanatomies or be configured for better navigation or delivery of thedevice 10. Additionally, or alternatively, some such curved sections maybe configured to allow the outer tubular member 102 to be predisposed tobe bent and/or deflected in a certain direction or configuration whencompression and/or tension forces are applied thereto. It iscontemplated that the outer tubular member 102 may be a laser cutmetallic tubing, a braid reinforced polymeric tubing, or other flexibletubular structure as desired.

Returning again to FIG. 4, the distal holding section 108 may be affixedto a distal end portion 114 of the intermediate tubular member 110. Thedistal holding section 108 may include a hub portion 136 and a tubularbody portion 138. In some instances, the hub portion 136 may be formedfrom a metal or metal alloy while the body portion 138 may be formedfrom a polymeric material, although this is not required. In someinstances, a proximal region 143 of the body portion 138 may be heatbonded to a distal end portion 137 of the hub portion 136, or otherwiseaffixed. The hub portion 136 may include a tapered intermediate region145 disposed between a proximal end portion 139 and the distal endportion 137.

In some embodiments, the outer tubular member 102 may include a metalring or tip adjacent the distal end 103 thereof for attaching one ormore pull wires thereto. It is contemplated that the outer tubularmember 102 may further include a lubricious liner, such as, but notlimited to a polytetrafluoroethylene (PTFE) liner. The proximal endportion 139 of the hub portion 136 may extend proximally into the lumen150 of the outer tubular member 102. In some instances, an outer surfaceof the proximal end portion 139 may form an interference fit with aninner surface of the outer tubular member 102. It is contemplated thatthe outer surface of the proximal end portion 139 and the inner surfaceof the outer tubular member 102 may be coupled in a tapered engagement.For example, the distal end 103 of the outer tubular member 102 mayflare radially outwards in the distal direction and/or the proximal endportion 139 may taper radially inward in the proximal direction. The twoangled surface may engage as the proximal end portion 139 is proximallyretracted within the outer tubular member 102. Other couplingarrangements may be used as desired.

It is contemplated that as the outer tubular member 102 is bent tonavigate the implantable device 10 to the desired location, the proximalend portion 139 may advance distally and disengage from the innersurface of the outer tubular member 102 creating a kink point orweakened region adjacent to the bonding region 146. Proximallyretracting the intermediate tubular member 110 to bring the intermediateregion 145 into contact with the outer tubular member 102 at contactpoint 148 and/or bringing the proximal end portion 139 into the outertubular member 102 and fixing the intermediate tubular member 110 inthis configuration may help prevent migration of the distal holdingsection 108 during navigation of the delivery device 100 to the desiredlocation. Such a configuration may also place the intermediate tubularmember 110 in tension while the distal holding section 108 applies acompression force on the outer tubular member 102, as will be discussedin more detail below. As discussed above, a locking mechanism 132 in thehandle assembly 120 may be utilized to releasably maintain the outertubular member 102 and the intermediate tubular member 110 in a desiredorientation.

FIG. 5 illustrates a top view of the handle assembly 120 of the deliverydevice 100 and FIG. 6 illustrates a bottom view of the handle assembly,approximately 180° from the view shown in FIG. 5. The handle assembly120 may include one or more ports 158, 160, 162 for delivering fluids,such as, but not limited to, a contrast and/or flushing fluid to thecavity 142 of the distal holding section 108. The flush ports 158, 160,162 may be in fluid communication with the lumens 150, 152, 154 of theouter, intermediate or inner tubular members 102, 110, 116, as desired.In some cases, and as an illustrative but non-limiting example, theflush port 158 may be in fluid communication with the outer tubularmember lumen 150 of the outer tubular member 102, the flush port 160 maybe in fluid communication with the intermediate tubular member lumen 152of the intermediate tubular member 110, and the flush port 162 may be influid communication with the inner tubular member lumen 154 of the innertubular member 116.

In some cases, one or more of the flush ports 158, 160, 162 may be usedto provide saline or another flushing to ensure that no air or debrisremains within any of the lumens 150, 152, 154 prior to use of thedelivery device 100. In some cases, one or more of the flush ports 158,160, 162 may be used to provide a continuous supply of fluid such as butnot limited to heparinized saline to one or more of the outer tubularmember lumen 150, the intermediate tubular member lumen 152 and/or theinner tubular member 154 during delivery and deployment of theimplantable device 10 to keep blood and debris from traveling proximallythrough one or more of the lumens 150, 152, 154 as well as to keepdebris from clogging or otherwise interfering with operation of thedelivery device 100.

FIGS. 7 and 8 illustrate fluid flow paths for each of the outer tubularmember lumen 150, the intermediate tubular member lumen 152 and theinner tubular member 154 as well as demonstrating relative movementpossible between the outer tubular member 102, the intermediate tubularmember 110 and the inner tubular member 116 and how this relativemovement can influence fluid flow paths.

FIG. 7 shows the outer tubular member 102, the intermediate tubularmember 110 and the inner tubular member 116 in a configuration that may,for example, be used for deploying the implantable device 10. As notedwith respect to FIG. 4, the tether 112 extends distally through theinner tubular member lumen 154 and the deployment funnel 118, and iscoupled to the tether retention feature 36. For example, as shown inFIG. 7, the tether 112 passes through the opening 38 and thus around thetether retention structure 36 and extends proximally back through theinner tubular member lumen 154. It will be appreciated that the tether112 does not interfere with fluid flow through the inner tubular memberlumen 154. FIG. 8 shows the outer tubular member 102, the intermediatetubular member 110 and the inner tubular member 116 axially separated toshow fluid flow paths. In comparing FIG. 7 and FIG. 8, it can be seen,for example, that the inner tubular member 116 may move axially relativeto the intermediate tubular member 110, between an advanced position(FIG. 8) in which the deployment funnel 118 extends distally into oreven through the distal holding section 108 and a retracted position(FIG. 7) in which the deployment funnel 118 seats into the hub portion136 and contacts the hub portion 136 at a contact point 180 (FIG. 7).Similarly, the intermediate tubular member 110 may move between aretracted position (FIG. 7) in which a proximal portion of the distalholding section 108 (such as the hub portion 136) seats within the outertubular member lumen 150 and an extended position (FIG. 8) in which theproximal portion of the distal holding section 108 (such as the hubportion 136) extends distally from the outer tubular member lumen 150.

With reference to FIG. 8, fluid paths for flushing the delivery device100 during a medical procedure use are easily seen. For example, arrows150 a illustrate how fluid may flow through the outer tubular memberlumen 150 and exterior of the distal holding section 108. Arrows 152 aillustrate how fluid may flow through the intermediate tubular memberlumen 152 and into/through the distal holding section 108. An arrow 154a illustrates how fluid may flow through the inner tubular member lumen154 and into/through the distal holding section 108. In comparing FIG. 7and FIG. 8, it will be appreciated that fluid may flow as indicated bythe arrow 154 a regardless of the position of the inner tubular member116 (and hence the deployment funnel 118) relative to the intermediatetubular member 110. In some cases, there is a desire to be able to flushfluid through the intermediate tubular member lumen 152 and/or the outertubular member lumen 150, even when the components are positioned asshown in FIG. 7. However, the hub portion 136 can be seen as potentiallyblocking fluid flow through the outer tubular member lumen 150 since thehub portion 136 may be abutting the distal end of the outer tubularmember 102 in the retracted configuration of FIG. 7. In some cases, thehub portion 136 may include one or more fluid flow channels (groovesand/or apertures) that align with the outer tubular member lumen 150 andpermit fluid flow therethrough.

Similarly, the deployment funnel 118, seated against the hub portion136, can be seen as potentially blocking fluid flow through theintermediate tubular member lumen 152 into the distal holding section108 but for fluid pathways formed between the interface between thedeployment funnel 118 and the hub portion 136 of the distal holdingsection 108. In some cases, the deployment funnel 118 may include one ormore fluid paths 119 that are formed through or along the deploymentfunnel 118. As indicated by arrows 181, fluid may flow through theintermediate tubular member lumen 152 and through the fluid paths 119into the distal holding section 108. As a result, fluid may flow pastthe contact point 180 between the funnel 118 and the hub portion 136that could otherwise block fluid flow. The fluid paths 119 may representfluid channels such as one or more apertures extending through thedeployment funnel 118 or grooves or recesses formed in an outer surfaceof the deployment funnel 118, for example.

FIGS. 9A through 14 provide illustrative but non-limiting examples ofdeployment funnels that include examples of the fluid paths and thusthat may be configured to permit fluid flow from the intermediatetubular member lumen 152 and/or the inner tubular member lumen 154 topass beyond the deployment funnel into the distal holding section 108and thus enable fluid flushing both before and during use of thedelivery device 100 while the deployment funnel is seated against thehub portion 136 of the distal holding section 108 and/or the headportion 32 of the docking member 30 is seated against the deploymentfunnel 118. While FIGS. 9A through 14 illustrate potential structuralchanges to the deployment funnel 118, and in some cases potentialstructural changes to one or more of the tubular members, it should benoted that in some cases, it is contemplated that rather than alteringthe deployment funnel 118, that the hub portion 136 itself may bealtered to permit fluid flow. For example, grooves or channels could beformed within the distal end portion 137 of the hub portion 136 thatwould permit fluid flow past the deployment funnel 118.

FIG. 9A is an end view of a deployment funnel 218 having an annularcross-sectional profile, at least about a periphery 220 of thedeployment funnel 218 while FIG. 9B provides a correspondingcross-sectional view of the deployment funnel 218, taken along the line9B-9B in FIG. 9A. The inner tubular member lumen 154 may be seen asextending centrally through the deployment funnel 218. In some cases,the deployment funnel 218 may include one or more flow channels, such asone or more, or a plurality of apertures 222 that extend through (e.g.,axially through) the wall of the deployment funnel 218, therebypermitting fluid to flow through the apertures 222 and thus flow pastthe deployment funnel 218 and into the distal holding section 108 (FIG.8). The apertures 222 may be mechanically formed through the deploymentfunnel 218, such as drilling the apertures 222 through the wall of thedeployment funnel 218 from a proximally facing surface of the deploymentfunnel 218 to a distally facing surface of the deployment funnel 218. Insome cases, the apertures 222 may instead be laser-cut.

While a total of four apertures 222 are shown, equidistantly spacedapart around the periphery 220, in some cases the deployment funnel 218may include five, six or more distinct apertures 222. In some cases, thedeployment funnel 218 may instead only have one, two, or three distinctapertures 222. While the apertures 222 are shown as being roughlycircular, in some cases, one or more of the apertures 222 may take anydesired shape. For example, one or more of the apertures 222 may beovoid or polygonal. In some cases, one or more of the apertures 222could be elongated in shape. For example, the deployment funnel 218could include a first elongated slot 224 and a second elongated slot226, each shown as extending between a pair of apertures 222. In somecases, the deployment funnel 218 could include additional elongatedslots, as desired. These are just examples.

FIG. 10 shows the outer tubular member 102, the intermediate tubularmember 110 and the inner tubular member 116 in a configuration that may,for example, be used for deploying the implantable device 10. As notedwith respect to FIG. 4, the tether 112 extends distally through theinner tubular member lumen 154 and through the deployment funnel 318,and is coupled to the tether retention feature 36. For example, as shownin FIG. 10, the tether 112 passes through the opening 38 and thus aroundthe tether retention structure 36 and extends proximally back throughthe inner tubular member lumen 154. It will be appreciated that thetether 112 does not interfere with fluid flow through the inner tubularmember lumen 154.

In FIG. 10, a deployment funnel 318, as will be discussed with respectto FIG. 11A, is seen attached to the distal end of the inner tubularmember 116 such that the inner tubular member lumen 154 extends throughthen central opening of the deployment funnel 318. Rather than includingapertures 222 (FIGS. 9A and 9B) that permit fluid flow paths 119, thedeployment funnel 318 includes one or more recesses or grooves 332 (FIG.11A) formed in a radially outward facing surface 330 of the flaredportion of the deployment funnel 318, providing a fluted periphery ofthe radially outward facing surface 330 of the deployment funnel 318.Turning to FIG. 11A, an end view of the deployment funnel 318 having afluted periphery 320 is shown. FIG. 11B provides a perspective view ofthe deployment funnel 318. The inner tubular member lumen 154 may beseen as extending centrally through the deployment funnel 318. In somecases, the fluted periphery 320 includes one or more, or a plurality ofrecesses or grooves 332 that are molded or otherwise formed into anouter surface 330 of the deployment funnel 318. The outer surface 330may be a proximally facing surface of the deployment funnel 318 withportions of the outer surface 330 contacting and/or seated against asurface of the hub portion 136 at contact points 180. For example, theprotruding portions of the fluted periphery 320 positioned between therecesses or grooves 332 may be seated against the surface of the hubportion 136, while a fluid pathway may be defined between the surface ofthe hub portion 136 (shown as a dashed line to illustrate) and thesurface of the funnel 318 defining the recesses or grooves 332. In somecases, the deployment funnel 318 may have a periphery with an annularprofile, and the recesses or grooves 332 may instead be cut into theouter surface 330 of the deployment funnel 318. The recesses or grooves332 may, for example, permit fluid flow past the deployment funnel 318from the intermediate tubular member lumen 152 and thus into the distalholding section 108 (FIG. 8). The deployment funnel 318 may include oneor more, or a plurality of recesses or grooves 332. While a total offour recesses or grooves 332 are shown, equidistantly spaced apartaround the periphery 320, in some cases the deployment funnel 318 mayinclude five, six or more distinct recesses or grooves 332. In somecases, the deployment funnel 218 may instead only have one, two, orthree distinct recesses or grooves 332.

FIG. 11C is a perspective view of a deployment funnel 318 a thatincludes a fluted periphery 320 a that includes one or more, or aplurality, of recesses or grooves 332 a that are molded or otherwiseformed into the deployment funnel 318 a. FIG. 11D provides an end viewof the deployment funnel 318 a. In some cases, while portions of thedeployment funnel 318 a between the recesses or grooves 332 a maycontact or seat against a surface of the hub portion 136 at contactpoints 180, the recesses or grooves 332 a may provide a fluid pathwaydefined between the surface of the hub portion 136 (shown as a dashedline to illustrate) and the surface of the funnel 318 a defining thegrooves 332 a. In some cases, the deployment funnel 318 a may have aperiphery with an annular profile, and the grooves 332 a may instead becut into an outer surface of the deployment funnel 318 a. The grooves332 a may, for example, permit fluid flow past the deployment funnel 318a from the intermediate tubular member lumen 152 and thus into thedistal holding section 108 (FIG. 8). While a total of four grooves 332 aare shown, equidistantly spaced apart around the periphery 320 a, insome cases the deployment funnel 318 a may include five, six or moredistinct grooves 332 a. In some cases, the deployment funnel 318 mayinstead only have one, two, or three distinct grooves 332 a.

In some cases, it is possible that the presence of the implantabledevice 10 within the distal holding section 108 (FIG. 2) may potentiallyimpact the flow of fluid passing beyond the deployment funnel 318 a fromthe inner tubular member lumen 154 and into the distal holding section108. In some cases, as illustrated, the deployment funnel 318 a mayinclude one or more recesses or grooves, such as curved notches 350,formed on a radially inwardly facing surface of the flared portion ofthe deployment funnel 318 a that facilitate fluid flow through thedeployment funnel 318 a from the inner tubular member lumen 154 and pastthe head portion 32 of the docking member 30 of the implantable device10 into the distal holding section 108. In some cases, each of the oneor more recesses, grooves, or notches 350 may be considered as curvednotches having a radially extending portion 352 and an axially extendingportion 354. As illustrated in FIG. 11E, which shows the implantabledevice 10 in position with the head portion 32 of the docking member 30seated against the radially inwardly facing surface of the flaredportion of the deployment funnel 318 a (as would occur inside the distalholding section 108), it can be seen that the radially extending portion352 of each of the one or more curved notches 350 extend radiallyoutward beyond the outer periphery of the head portion 32 of the dockingmember 30 extending proximally from the implantable device 10. Thedeployment funnel 318 a may include one or more, or a plurality ofrecesses, grooves, or notches 350 formed on the radially inwardly facingsurface to define one or more, or a plurality of fluid flow pathsbetween the radially inwardly facing surface of the deployment funnel318 a and a surface of the head portion 32 of the docking member 30, forexample. While a total of four recesses, grooves, or notches 350 areshown, equidistantly spaced apart, in some cases the deployment funnel318 a may include five, six or more recesses, grooves, or notches 350.In some cases, the deployment funnel 318 a may instead only have one,two, or three recesses, grooves, or notches 350.

FIG. 12 is a partial cross-sectional view showing the outer tubularmember 102, the intermediate tubular member 110 and the inner tubularmember 116 in a configuration that may, for example, be used fordeploying the implantable device 10. As noted with respect to FIG. 4,the tether 112 extends distally through the inner tubular member lumen154 and through the deployment funnel 118, and is coupled to the tetherretention feature 36. For example, as shown in FIG. 12, the tether 112passes through the opening 38 and thus around the tether retentionstructure 36 and extends proximally back through the inner tubularmember lumen 154. It will be appreciated that the tether 112 does notinterfere with fluid flow through the inner tubular member lumen 154.

As shown in FIG. 12, the deployment funnel 118 may not include featuresthat enable fluid flow to pass the contact point 180. In some cases, thedeployment funnel 118 may include one or more of the apertures, groovesand other features that permit fluid flow to pass the contact point 180.In some cases, the intermediate tubular member 110 may include one ormore apertures 190 that enable fluid flowing through the outer tubularmember lumen 150 to flow through the one or more apertures 190 from theouter tubular member lumen 150, indicated by arrows 181, and enter theintermediate tubular member lumen 152. The apertures 190 may extendthrough the annular sidewall of the intermediate tubular member 110, orthe apertures may be formed at a joint between joined portions of theintermediate tubular member 110, such as at the junction between theintermediate tubular member 110 and the hub portion 136. In some cases,the inner tubular member 116 may include one or more apertures 192 thatenable fluid flowing through the intermediate tubular member lumen 152to flow through the one or more apertures 192, indicated by arrows 181,and enter the inner tubular member lumen 154. The apertures 192 mayextend through the annular sidewall of the inner tubular member 116, orthe apertures may be formed at a joint between joined portions of theinner tubular member 116, such as at the junction between the innertubular member 116 and the deployment funnel 118. As a result, fluidflowing through the outer tubular member lumen 150 and/or fluid flowingthrough the intermediate tubular member lumen 152 may enter the innertubular member lumen 154 proximate the distal holding section 108, andthus flow through and distally out of the deployment funnel 118 aroundthe head portion 32 of the docking member 32 into the distal holdingsection 108. Thus, the outer tubular member lumen 150 and/or theintermediate tubular member lumen 152 may be flushed with fluid (e.g.,saline) from the proximal end of the delivery device 100 (e.g., from oneor more fluid ports in the handle assembly 120, with the fluid beingexpelled through the interior of the deployment funnel 118 into thedistal holding section 108.

FIG. 13 is a side view of a deployment funnel 418 having an outersurface 430. In some cases, a helical groove 432 may be formed withinthe outer surface 430. While a total of three windings of the helicalgroove 432 are illustrated, it will be appreciated that in some casesthe helical groove 432 may have a relatively tighter pitch, and thuswould have more than three windings extending around the deploymentfunnel 418. In some cases, there may be a relationship between pitch(and hence number of windings) and the relative width and/or depth ofthe helical groove 418. For example, with a relatively large pitch (asillustrated), the helical groove 418 may be relatively larger (in widthand/or depth) to accommodate fluid flow therethrough. Alternatively,with a smaller pitch, and hence a larger number of windings, the helicalgroove 418 may be relatively smaller (in width and/or depth) as theremay effectively be a larger number of channels for fluid to flow pastthe deployment funnel 418 and into the distal holding section 108. Itwill be appreciated that the helical groove 432 may be formed as aleft-handed or a right-handed helix.

FIGS. 9A, 9B, 11A, 11B, 11C, 11D, 11E, 12 and 13 show examples ofdeployment funnels that include structure to facilitate fluid flow pastthe deployment funnel. In some cases, the deployment funnel itself maybe configured to permit fluid to flow through the deployment funnel. Forexample, in some cases the deployment funnel may be formed of a porousmaterial. In some cases, the deployment funnel may be a polymericstructure having a plurality of micro-scale passages, holes and the likeformed within the polymeric structure that enable fluid to flow through.In some cases, the deployment funnel may be formed of an open-celledfoam, for example. In some cases, the deployment funnel may be formed offused fibers. The deployment funnel may, for example, may be formed ofwoven or non-woven materials.

FIG. 14 provides an example of a deployment funnel 518 having alattice-like or mesh structure. In FIG. 14, the deployment funnel 518may be seen as being braided, including a first plurality of windings540 extending helically in a first direction and a second plurality ofwindings 542 extending helically in second direction different from thefirst direction such that the first plurality of windings 540 intersectthe second plurality of windings 542 at a number of intersection points544. In some cases, the intersection points 544 may be spaced relativelycloser together, providing relatively smaller voids 546 defined bysurrounding windings 540, 542. In some cases, the intersection points544 may be spaced relatively farther apart, providing relatively largervoids 546 defined by surrounding windings 540, 542. It will beappreciated that the particular dimensions may be a function of desiredfluid flow through the deployment funnel 518 relative to a desiredmechanical strength of the deployment funnel 518.

The materials that can be used for the various components of thedelivery devices, such as delivery device 100 (and/or other deliverystructures disclosed herein) and the various members disclosed hereinmay include those commonly associated with medical devices. Forsimplicity purposes, the following discussion makes reference thedelivery device 100 and components of thereof. However, this is notintended to limit the devices and methods described herein, as thediscussion may be applied to other similar delivery systems and/orcomponents of delivery systems or devices disclosed herein.

The delivery device 100 and/or other components of delivery system maybe made from a metal, metal alloy, polymer (some examples of which aredisclosed below), a metal-polymer composite, ceramics, combinationsthereof, and the like, or other suitable material. Some examples ofsuitable polymers may include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP),polyoxymethylene (POM, for example, DELRIN® available from DuPont),polyether block ester, polyurethane (for example, Polyurethane 85A),polypropylene (PP), polyvinylchloride (PVC), polyether-ester (forexample, ARNITEL® available from DSM Engineering Plastics), ether orester based copolymers (for example, butylene/poly(alkylene ether)phthalate and/or other polyester elastomers such as HYTREL® availablefrom DuPont), polyamide (for example, DURETHAN® available from Bayer orCRISTAMID® available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA),silicones, polyethylene (PE), Marlex high-density polyethylene, Marlexlow-density polyethylene, linear low density polyethylene (for exampleREXELL®), polyester, polybutylene terephthalate (PBT), polyethyleneterephthalate (PET), polytrimethylene terephthalate, polyethylenenaphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI),polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide(PPO), poly paraphenylene terephthalamide (for example, KEVLAR®),polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMSAmerican Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinylalcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments the polymer can be blendedwith a liquid crystal polymer (LCP). For example, the mixture cancontain up to about 6 percent LCP.

Some examples of suitable metals and metal alloys include stainlesssteel, such as 304V, 304L, and 316LV stainless steel; mild steel;nickel-titanium alloy such as linear-elastic and/or super-elasticnitinol; other nickel alloys such as nickel-chromium-molybdenum alloys(e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY®C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys,and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL®400, NICKELVAC® 400, NICORROS® 400, and the like),nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such asMP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 suchas HASTELLOY® ALLOY B2®), other nickel-chromium alloys, othernickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-ironalloys, other nickel-copper alloys, other nickel-tungsten or tungstenalloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenumalloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like);platinum enriched stainless steel; titanium; combinations thereof; andthe like; or any other suitable material.

In at least some embodiments, portions or all of the delivery device 100and/or other components of delivery system may be doped with, made of,or otherwise include a radiopaque material. Radiopaque materials areunderstood to be materials capable of producing a relatively brightimage on a fluoroscopy screen or another imaging technique during amedical procedure. This relatively bright image aids the user of thedelivery device 100 in determining its location. Some examples ofradiopaque materials can include, but are not limited to, gold,platinum, palladium, tantalum, tungsten alloy, polymer material loadedwith a radiopaque filler, and the like. Additionally, other radiopaquemarker bands and/or coils may also be incorporated into the design ofthe delivery device 100 to achieve the same result.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of thedisclosure. This may include, to the extent that it is appropriate, theuse of any of the features of one example embodiment being used in otherembodiments. The invention's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. A delivery device for delivering an implantableleadless pacing device, the delivery device comprising: an outer tubularmember including an outer tubular member lumen extending from a proximalend to a distal end thereof; an intermediate tubular member coaxiallyand slidingly disposed within the outer tubular member lumen, theintermediate tubular member including an intermediate tubular memberlumen extending from a proximal end to a distal end thereof; an innertubular member coaxially and slidingly disposed within the intermediatetubular member lumen, the inner tubular member including an innertubular member lumen extending from a proximal end to a distal endthereof; a distal holding section extending distally of a distal end ofthe intermediate tubular member, the distal holding section defining acavity therein for receiving an implantable leadless pacing device; anda deployment funnel fixedly attached to the distal end of the innertubular member, the deployment funnel moveable between an advancedposition in which the deployment funnel extends distally within thedistal holding section and a retracted position in which the deploymentfunnel is seated within a proximal portion of the distal holdingsection; the deployment funnel configured to permit fluid flow from thedistal end of the intermediate tubular member lumen into the distalholding section when the deployment funnel is in the retracted position.2. The delivery device of claim 1, wherein the deployment funnelcomprises one or more apertures extending through the deployment funnelthat are in fluid communication with the intermediate tubular memberlumen so that fluid can flow from the distal end of the intermediatetubular member lumen and pass through the one or more apertures into thedistal holding section.
 3. The delivery device of claim 1, wherein thedeployment funnel comprises one or more grooves that are in fluidcommunication with the intermediate tubular member lumen so that fluidcan flow from the distal end of the intermediate tubular member lumenand pass through the one or more grooves into the distal holdingsection.
 4. The delivery device of claim 1, wherein at least a portionof the deployment funnel comprises a porous material that enables fluidflow through pores thereof.
 5. The delivery device of claim 1, whereinat least a portion of the deployment funnel comprises a scaffoldingmaterial including voids that enable fluid flow therethrough.
 6. Thedelivery device of claim 1, wherein the deployment funnel is furtherconfigured to provide a fluid coupling between the inner tubular memberlumen and the distal holding section when the deployment funnel is inthe retracted position.
 7. The delivery device of claim 6, wherein thedeployment funnel includes a central aperture that aligns with the innertubular member lumen.
 8. The delivery device of claim 1, furthercomprising a tether removably disposed within the inner tubular memberlumen and extending through the deployment funnel, the tether beingconfigured to engage the implantable leadless pacing device.
 9. Adelivery device for delivering an implantable leadless pacing device,the delivery device comprising: an outer tubular member defining anouter tubular member lumen extending from a proximal end to a distal endthereof; an intermediate tubular member moveably disposed within theouter tubular member lumen and defining an intermediate tubular memberlumen extending from a proximal end to a distal end thereof; a distalholding section extending distally of a distal end of the intermediatetubular member and configured to accommodate an implantable leadlesspacing device at least partially within the distal holding section, theintermediate tubular member moveable between a retracted position inwhich a proximal portion of the distal holding section seats within theouter tubular member lumen and an extended position in which theproximal portion of the distal holding section extends distally from theouter tubular member lumen; an inner tubular member moveably disposedwithin the intermediate tubular member lumen and defining an innertubular member lumen extending from a proximal end to a distal endthereof; and a deployment funnel fixedly secured to the distal end ofthe inner tubular member, the inner tubular member moveable between anextended position in which the deployment funnel extends distally withinthe distal holding section and a retracted position in which thedeployment funnel is seated within a proximal portion of the distalholding section, the deployment funnel configured to permit fluid flowfrom the distal end of the intermediate tubular member lumen into thedistal holding section when in the retracted position.
 10. The deliverydevice of claim 9, wherein the deployment funnel comprises one or moreapertures extending through the deployment funnel in order to permitfluid to flow past the deployment funnel in the retracted position. 11.The delivery device of claim 9, wherein the deployment funnel comprisesone or more grooves on a surface of the deployment funnel in order topermit fluid to flow past the deployment funnel in the retractedposition.
 12. The delivery device of claim 9, wherein at least a portionof the deployment funnel comprises a porous material that enables fluidflow therethrough.
 13. The delivery device of claim 9, wherein the innertubular member extends centrally through a central aperture of thedeployment funnel.
 14. A delivery system for delivering a leadlesscardiac pacemaker (LCP), the delivery system comprising: a deflectionshaft defining a deflection shaft lumen; an extension shaft extendingthrough the deflection shaft lumen, the extension shaft defining anextension shaft lumen; an LCP sleeve secured to a distal end of theextension shaft and extending distally therefrom, the LCP sleeveconfigured to accommodate an LCP at least partially within the LCPsleeve for delivery; a deployment shaft extending through the extensionshaft lumen, the deployment shaft defining a deployment shaft lumen; anda deployment funnel fixedly attached to a distal end of the deploymentshaft, the deployment funnel including a central aperture, thedeployment funnel configured to engage the LCP for holding the LCP inplace while the LCP sleeve is withdrawn proximally relative to the LCP;the deployment funnel configured to accommodate a tether extendingwithin the deployment shaft lumen and through the central aperture ofthe deployment funnel, the central aperture aligning with the deploymentshaft lumen; the deployment funnel including one or more fluidstructures that enable fluid to flow from the extension shaft lumen anddistally beyond the deployment funnel into the LCP sleeve.
 15. Thedelivery system of claim 14, wherein the deployment funnel comprises oneor more grooves on a surface of the deployment funnel in order to permitfluid to flow past the deployment funnel into the LCP sleeve.
 16. Thedelivery system of claim 15, wherein the one or more grooves are formedon a radially outward facing surface of the deployment funnel seatedagainst a hub portion of the LCP sleeve.
 17. The delivery system ofclaim 15, wherein the one or more grooves are formed on a radiallyinward facing surface of the deployment funnel seated against a headportion of a docking member of the LCP.
 18. The delivery system of claim15, wherein the deployment shaft includes an aperture extending througha sidewall thereof providing a fluid pathway between the extension shaftlumen and the deployment shaft lumen permitting fluid to pass from theextension haft lumen into the deployment shaft lumen and distallythrough the deployment funnel into the LCP sleeve.
 19. The deliverysystem of claim 14, wherein a distal end of the deployment shaft extendsinto the central aperture of the deployment funnel.